21 U.S. Code § 360bbb–8a - Optimizing global clinical trials

(1)work with other regulatory authorities of similar standing, medical research companies, and international organizations to foster and encourage uniform, scientifically driven clinical trial standards with respect to medical products around the world; and

(2)enhance the commitment to provide consistent parallel scientific advice to manufacturers seeking simultaneous global development of new medical products in order to—

In this section, the term “medical product” means a drug, as defined in subsection (g) ofsection
321 of this title, a device, as defined in subsection (h) of such section, or a biological product, as defined in section
262(i) of title
42.

(c) Savings clause

Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter.